MAUDE Adverse Event Report: ABBOTT QUADRA ASSURA ICD; No Match

Model Number CD3367-40QC

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/31/2023

Event Type  malfunction  

Event Description

During an unrelated procedure, a set screw anomaly occurred when connecting the left ventricular (lv) lead to the header of the device.The set screw was fully tightened, however, upon the last twist of the screw driver, the set screw appeared to have lost torque.Electrical measurements were normal and the lv lead was securely connected to the device, so the physician elected not to perform any intervention and implanted the device.The patient was in stable condition.

• Brand Name: QUADRA ASSURA ICD
• Type of Device: No Match
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 17558310
• MDR Text Key: 321274379
• Report Number: 2017865-2023-38476
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CD3367-40QC
• Device Lot Number: A000140941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/01/2023
• Initial Date FDA Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1